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mibefradil · 1 trial · 1 indication
Safety will be assessed by clinical laboratory tests, physical examinations, vital sign measurements, continuous, real time, 3-lead ECG monitoring, concomitant medication documentation and adverse event monitoring.
| Arm | Type | Description |
|---|---|---|
| Mibefradil | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| mibefradil | DRUG | 25 mg tablets for oral administration given for 7 days at a total daily dose beginning at 100 mg per day divided into four doses. Doses will be incremented in successive cohorts by 25 mg/day up to 400 mg/day. |
| Placebo | OTHER | 1 out of 6 patients per cohort will receive placebo tablets identical in appearance and number to the active mibefradil arm. |
Inclusion Criteria: 1. Normal healthy volunteers aged 19 to 55 years, male or female, and willing and able to sign informed consent; 2. Females must have a negative pregnancy test at screening and be practicing a suitable method of birth control so that, in the opinion of the Investigator, they wil...
Mibefradil with Radiation is an investigational small molecule being studied for use in Glioblastoma Multiforme (GBM), a type of brain cancer. It is being developed by Jazz Pharmaceuticals plc (JAZZ) and is currently in Phase 1 clinical development. The drug has also been studied in healthy volunteers.
Mibefradil with Radiation is being developed by Jazz Pharmaceuticals plc, which trades under the ticker symbol JAZZ. The company is conducting clinical trials to evaluate the drug's safety and potential use in treating Glioblastoma Multiforme (GBM).
Mibefradil with Radiation is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed to assess its safety in healthy volunteers and in patients with Glioblastoma Multiforme (GBM).
Mibefradil with Radiation has been studied in two completed Phase 1 trials. NCT01550458 evaluated the drug given four times a day in 30 healthy volunteers in the United States. NCT02202993 studied mibefradil combined with hypofractionated re-irradiation therapy in 18 patients with recurrent Glioblastoma Multiforme (GBM).
Mibefradil with Radiation is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials have focused on safety and dosing, and the drug has not yet progressed to later-stage trials or regulatory submission.